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AudioKey - Hearing aid fitting/programming application software - ARTG 433075

Access comprehensive regulatory information for AudioKey - Hearing aid fitting/programming application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 433075 and sponsored by MED-EL Implant Systems Australasia Pty Ltd, manufactured by Med-El Elektromedizinische Gerate GmbH in Austria. The device registration started on January 09, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class III
ARTG 433075
Class III
AudioKey - Hearing aid fitting/programming application software
ARTG ID: 433075
Good Name: MED-EL Implant Systems Australasia Pty Ltd - AudioKey - Hearing aid fitting/programming application software
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Intended Purpose

A mobile application to remotely control and provide status information of compatible non-implantable MED-EL products

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
433075
Start Date
January 09, 2024
Effective Date
November 15, 2024
Manufacturer
Country
Austria
Address
Furstenweg 77a, Innsbruck, 6020